Rationale and Design of the TAILOR-HCM Multicenter Randomized Controlled Trial: Transapical Beating-Heart Septal...

Area of Science:

• Cardiology
• Cardiac Surgery
• Medical Devices

Background:

• Septal myectomy is the standard treatment for drug-refractory obstructive hypertrophic cardiomyopathy (oHCM).
• Conventional septal myectomy (CSM) is technically complex and limited to specialized centers.
• Transapical beating-heart septal myectomy (TA-BSM) offers a less invasive approach under echocardiographic guidance.

Purpose of the Study:

• To evaluate the safety and efficacy of TA-BSM compared to CSM in patients with oHCM.
• To determine if TA-BSM is noninferior to CSM in relieving left ventricular outflow tract (LVOT) obstruction.
• To assess secondary outcomes including hemodynamic parameters, quality of life, and safety.

Main Methods:

• The TAILOR-HCM trial is a multicenter, randomized, controlled, assessor-blinded, noninferiority trial.
• 216 symptomatic oHCM patients were randomized 1:1 to TA-BSM or CSM.
• The primary endpoint is LVOT obstruction relief at 12 months (resting gradient <30 mm Hg, Valsalva <50 mm Hg).

Main Results:

• This section will report the findings of the TAILOR-HCM trial once available.
• Key outcomes include comparative analysis of LVOT obstruction relief between TA-BSM and CSM.
• Safety outcomes, including all-cause mortality, will be assessed at 12 months.

Conclusions:

• TAILOR-HCM is the first multicenter randomized trial comparing TA-BSM and CSM for oHCM.
• The study aims to provide evidence for TA-BSM as a potential alternative surgical approach.
• If proven effective and safe, TA-BSM could expand treatment options for oHCM patients.